Recall Z-1189-2021— Physio-Control, Inc.
Class II · Ongoing
Class II FDA medical device recall by Physio-Control, Inc., initiated 2021-01-14. FDA's recall record names no specific 510(k) clearance for this event. Product: PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.. Reason: Due to complaints received regarding missing lid magnets which may result in premature battery depletion..
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-01-14
- Firm location
- Redmond, WA, United States
Product description
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.
Reason for recall
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.